Artikel
Response and Radiographic Progression in Biologic-naïve and Biologic-experienced Patients With Rheumatoid Arthritis Treated with Sirukumab
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Autoren
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Carter Thorne
- University of Toronto and Southlake Regional Health Centre, Newmarket, ON, Canada
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George Karpouzas
- Division of Rheumatology, Harbor-UCLA Medical Center, Torrance, CA, USA
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Tsutomu Takeuchi
- Keio University School of Medicine, Tokyo, Japan
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Shihong Sheng
- Janssen Research & Development, LLC, Spring House, PA, USA
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Weichun Xu
- Janssen Research & Development, Inc., Malvern, United States of America
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Steven Xu
- Janssen Research & Development, LLC, Spring House, PA, USA
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Regina Kurrasch
- GlaxoSmithKline, Collegeville, PA, USA
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Kaiyin Fei
- Janssen Research & Development, LLC, Spring House, PA, USA
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Benjamin Hsu
- Janssen Research & Development, Inc., Spring House, United States of America
| Veröffentlicht: | 29. August 2016 |
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Gliederung
Text
Background: Efficacy and safety of sirukumab, a selective, high-affinity human monoclonal antibody to IL-6, have recently been evaluated in a global Phase 3 study in patients (pts) with active rheumatoid arthritis (RA) refractory to conventional, disease-modifying anti-rheumatic drugs (DMARDs). The efficacy and radiographic progression of sirukumab were compared in subgroups of pts with active RA despite DMARD treatment who previously received biologic therapy (biologic-experienced) and who previously only received synthetic DMARDs (biologic-naïve).
Methods: Pts were randomized (1:1:1) to sirukumab subcutaneous (SC) 50mg q4w, sirukumab SC 100mg q2w, or placebo SC q2w. Pts on placebo with insufficient (<20%) improvement at Wks 18 or 40 or still on placebo at Wk 52 were re-randomized to sirukumab treatment (1 of the 2 doses). The co-primary efficacy endpoints were: Wk 16 ACR20 response and Wk 52 change from baseline (BL) in modified van der Heijde/Sharp [vdH-S] radiographic score. This post-hoc analysis compared efficacy for biologic-naïve and -experienced pts within biologic experience category for sirukumab vs placebo, and across experience category within sirukumab dose group.
Results: Improvements were observed in all outcomes for sirukumab vs placebo, regardless of prior biologic use (all P<0.001 within biologic experience categories; Table 1 [Tab. 1]). 34.9% (583/1,670) of pts were prior biologic-experienced. At BL, compared with biologic-naïve pts, biologic-experienced pts had longer disease duration (mean, 11 vs 7 yrs; P<0.0001) and worse HAQ-DI scores (mean, 1.58 vs 1.49; P=0.02). No differences between prior biologic-naïve and -experienced pts were observed in either sirukumab dose group for the co-primary endpoints (both P≥0.1), as well as for Wk 24 ACR50 response, DAS28 (CRP) remission, or Wk 52 mean DAS28 change from BL (all P≥0.1).
Conclusion: Both sirukumab doses significantly reduced RA signs/symptoms and inhibited radiographic progression vs placebo within prior biologic use categories, with comparable efficacy observed between biologic-naïve and -experienced pts for both sirukumab doses.
